FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DETECTACULT
K Number: K854619
·
Decision Mar 3, 1986
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
96
Applicant Total
11
Review Days
105
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Basic Information
- Device Name
- DETECTACULT
- K Number
- K854619
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.6550
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Immunostics Co., Inc.
- Date Received
- November 18, 1985
- Decision Date
- March 3, 1986
- Product Code
- KHE
- Advisory Committee
- Hematology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KHE | Reagent, Occult Blood | FDA class 2 | Hematology |
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Other Clearances by Immunostics Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K926569 | IMMUNO RA UNDILUTED | Apr 6, 1993 | Substantially Equivalent |
| K902360 | HEMA-SCREEN | Jul 27, 1990 | Substantially Equivalent |
| K894780 | IMMUNO/ASO | Oct 16, 1989 | Substantially Equivalent |
| K883685 | IMMUNO/FEBRILE ANTIGENS | Sep 28, 1988 | Substantially Equivalent |
| K872910 | IMMUNO/SLE | Aug 12, 1987 | Substantially Equivalent |
| K863741 | IMMUNO-CEPT D (BETA-MONOCLONAL) | Nov 13, 1986 | Substantially Equivalent |
| K853105 | IMMUNO-IM | Sep 3, 1985 | Substantially Equivalent |
| K842110 | SLIDE PREGNANCY TEST | Jul 12, 1984 | Substantially Equivalent |
| K834390 | IMMUNO-CRP | Feb 3, 1984 | Substantially Equivalent |
| K834391 | IMMUNO-RA | Feb 3, 1984 | Substantially Equivalent |